Kornimate/medical-research-clean huggingface dataset:
systemic avastin therapy in age-related macular degeneration

Conditions: Macular Degeneration

Summary: choroidal neovascularisation (cnv) in age-related macular degeneration is one of the major causes of blindness in the western world. it is already known that the vascular endothelial growth factor (vegf) plays a major role in the development of cnv. photodynamic therapy (pdt), subretinal surgery, and intravitreal injection of vegf- inhibitors are the common treatments. these methods are either very invasive or need to be repeated several times over long periods of time in order show some effect. furthermore pdt can only be performed in eyes with pigment epithelium detachments (ped) of maximum 50% of the avascular zone, while intravitreal injections can lead to endophthalmitis and acute glaucoma. a systemic treatment, which would only need to be administered 3 times within 6 weeks would be a major effort in macular degeneration therapy.

bevacizumab (avastin®, genentech inc.) is a new anti-vascular endothelial growth factor (anti-vegf) which has shown promising results as a combination therapy with 5-fluorouracil, leucovorin, and oxaliplatin in first-line treatment of metastatic colorectal cancer14,15. since intraocular anti-vegf therapies for cnv in amd have already shown promising results, the idea of this study is to administer the anti-vegf bevacizumab intravenously, as a systemic therapy, in amd-patients. the rationale of the present study is to determine the effect of systemic bevacizumab therapy in patients with fibrovascular pigment epithelium detachment (ped), involving the geometric center of the foveal avascular zone, in comparison to placebo treatment with sodium chloride 0,9%. the patients will receive 3 intravenous infusions of 5mg/kg bevacizumab at 2 weeks intervals or 3 intravenous infusions of 100ml sodium chloride 0,9% at 2 weeks intervals. medical internal reviews, etdrs and radner visual acuity assessment, ophthalmologic examinations, ocular imaging with oct 3, multifocal erg, fluorescein angiography, and indocyanine angiography will be performed. the follow-up time is 6 months.

Eligibility criteria:
inclusion criteria: * amd patients with fibrovascular pigment epithelium detachment (ped), subfoveal choroidal neovascularisations (cnv) extending under the geometric center of the foveal avascular zone, and a central retinal thickness of at least 300 microns. exclusion criteria: * patients who had arterial thromboembolic diseases * patients with: cancer, proteinuria, renal impairment, hepatic dysfunction, vision threatening ophthalmic diseases other than amd

Keywords: exudative neovascular amd avastin systemic exudative age-related macular degeneration
a study evaluating the efficacy and impact on health-related quality of life of levocetirizine in adults with seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: the study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related quality of life.


Eligibility criteria:
inclusion criteria: * subjects with a history of sar symptoms * a positive skin prick test at least one grass allergen * moderate - severe sar symptoms at baseline * women of childbearing potential must use a medically acceptable form of contraception * 80% compliance on run in study medication and 80% compliance on completing the diary exclusion criteria: * the presence of any clinically significant comorbid disease which may interfere with the study assessments * the presence of renal disease * pregnant or breastfeeding * subject is currently participating in another clinical trial * known hypersensitivity to piperazines or any of the excipients * intake of medications prohibited before the start of the trial * subjects who started or changed the dose of immunotherapy * rhinitis medicamentosa * subjects with a recent history (within the last 2 years) of drug or alcohol abuse

Keywords: levocetirizine xyzal seasonal allergic rhinitis total symptom score quality of life
aortic calcium: epidemiology and progression -- ancillary to mesa

Conditions: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Arteriosclerosis

Summary: to study the epidemiology of aortic calcium.

background: aortic calcium measured by computed tomography occurs earlier in life than other subclinical (that is, asymptomatic) markers of cardiovascular disease (cvd), shows a wide range, and is common in women. the large size of the aorta and relative lack of image artifact from motion make it ideal for radiographic quantitative imaging. this study is ancillary to and coordinated with the multi-ethnic study of atherosclerosis (mesa), a large prospective epidemiologic study investigating multiple subclinical cvd measures and cvd risk factors. subclinical measures in mesa include coronary calcium, carotid ultrasound, cardiac magnetic resonance imaging, and the ankle/brachial blood pressure index. the extensive cvd risk factor measurements include both traditional risk factors and newer measures such as inflammatory and genetic markers. design narrative: this ancillary study will determine the epidemiology of aortic calcium in 2000 randomly selected (from 6500 total) mesa participants. questions to be addressed include predictors of aortic calcium progression; associations of aortic calcium and aortic calcium progression with other subclinical cvd measures, cvd risk factors, and demographics; and the prognostic significance of aortic calcium. the project has three primary specific aims: 1) to predict the cross-sectional aortic calcium burden as a function of other subclinical cvd measures and cvd risk factors; 2) to predict aortic calcium progression as a function of other subclinical cvd measures and cvd risk factors, and 3) to predict aortic calcium progression as a function of progression of selected subclinical cvd measures and cvd risk factors. the two secondary specific aims are 1) to contrast the results of the three primary specific aims for men vs. women, and for four major ethnic groups (white, hispanic, black, and asian); and 2) to provide a database for future evaluation of whether aortic calcium and/or aortic calcium progression independently predict subsequent myocardial infarction, stroke, and other cvd events.

Eligibility criteria:
participation in the original mesa study
study of herbal formula corresponding to syndrome in treating post percutaneous coronary intervention (pci) patients with coronary heart disease (chd)

Conditions: Coronary Heart Disease

Summary: we conduct this clinical trial to determine the effects of xuefu zhuyu capsule (based on tcm "zheng hou" theory) in helping recovery from coronary heart disease(chd)after pci and find out whether this kind of effecacy is much better within patients administered with tcm syndrome-based individualized medication.

the effectiveness of a chinese herbal formulae is not completely based on the disease or some biomedical indexes, but much more on the tcm syndrome(chinese name:zheng hou)which is generalized from patients' tcm signs and symptoms. thus, conventional medical curative effecacy evaluation system seems not to so fit for tcm clinical studies. although many clinical studies from chinese literature have reported the beneficial effects of various of tcm herbal agents in improving symptoms and signs as well as antagonism of specific pathological changes in chd patients, most of these trials are lack of well-designed methodologies and the reliability of results still remains unclear. therefore, we designed this clinical trial, with a randomized, placebo controlled way, to evaluate the curative effects of xuefu zhuyu capsule(a chinese herbal medicine)in patients with post-pci chd patients and find out whether this effects will be better displayed within subjects administered with syndrome-based individualized medication.

Eligibility criteria:
inclusion criteria: * 18-75 years old * clinical diagnosis of coronary heart disease (confirmed by coronary angiography) * successfully received interventional therapy (ptca or pci) * belong to tcm blood-stasis syndrome * must be able to swallow tablets * able to give written informed consent exclusion criteria: * symptomatic congestive heart failure(new york heart association class iii-iv) * females during pregnancy or lactation * serious dysfunction in important organs (liver, lung, kidney，et al) * use of concomitant chinese herbal medicine * already attend other clinical trial

Keywords: coronary heart disease pci traditional chinese medicine quality of life
study evaluating long-term safety of effexor xr in patients with major depression.

Conditions: Depression

Summary: phase iii long-term safety study of effexor xr in patients with major depression.


Eligibility criteria:
inclusion criteria: * patients who complete the phase iii double-blind study (protocol number 0600b1-816) exclusion criteria: * patients with schizophrenia or any other psychotic disorder * patients with history or presence of bipolar disorder

Keywords: depression
closed-loop in adults with t2d not requiring dialysis

Conditions: Type 2 Diabetes

Summary: the main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over an 8 week period in adults with type 2 diabetes (t2d). this study builds on previous and on-going studies of closed-loop systems that have been performed in cambridge in adults with type 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting. this is an open-label, single centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants' usual insulin therapy in random order. each treatment arm is 8 weeks long with a 2-4 week washout period between treatments. a total of up to 30 participants with t2d will be recruited through outpatient clinics to allow for 24 completed participants available for assessment. participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (cgm) and closed-loop insulin delivery system). participants in the control arm will continue with standard therapy and will wear a blinded cgm system. the primary outcome is time spent with glucose levels in the target range between 3.9 and 10.0 mmol/l as recorded by cgm. secondary outcomes are the time spent with glucose levels above and below target, as recorded by cgm, and other cgm-based metrics in addition to insulin requirements. safety evaluation comprises the tabulation of severe hypoglycaemic episodes.


Eligibility criteria:
inclusion criteria: 1. age 18 years or over 2. diagnosis of type 2 diabetes using standard diagnostic practice 3. current treatment with subcutaneous insulin 4. screening hba1c ≤ 11% (97mmol/mol) on analysis from local laboratory 5. subject is willing to perform regular finger-prick blood glucose monitoring 6. willingness to wear study devices 7. literate in english exclusion criteria: 1. physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator 2. known or suspected allergy to insulin 3. lack of reliable telephone facility for contact 4. pregnancy, planned pregnancy, or breast feeding 5. severe visual impairment 6. severe hearing impairment 7. medically documented allergy towards the adhesive (glue) of plasters 8. serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor 9. illicit drugs abuse 10. prescription drugs abuse 11. alcohol abuse

Keywords: diabetes type 2 diabetes closed-loop artificial pancreas insulin pump therapy continuous glucose monitoring
magnesium vs placebo for tonsillectomy

Conditions: Pain

Summary: this study is a double-blind randomized controlled trial using intravenous magnesium versus placebo to determine if systemic magnesium can decrease postoperative pain in pediatric patients undergoing tonsillectomy. participants will be in one of two arms. those in arm 1 will receive magnesium (30 mg/kg bolus followed by a 10mg/kg/hr infusion) while those in arm 2 will receive an equal volume of normal saline bolus followed by infusion (placebo). the primary objective is to determine if systemic magnesium will decrease postoperative pain in patients undergoing tonsillectomy. the secondary objectives will determine if systemic magnesium administration is associated with a decrease in opioid-related side effects, decrease the incidence of emergence delirium, and improve postoperative functional recovery. the study hypothesis is that the use of intravenous magnesium will decrease postoperative pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and improve functional recovery in patients undergoing tonsillectomy.


Eligibility criteria:
inclusion criteria: * patients aged 4-10 years old undergoing tonsillectomy by a single surgeon and under the care of that participating surgeon * american society of anesthesiology (asa) patient classification of i-iii exclusion criteria: * physical or developmental delay * psychiatric illness * current use of sedative or anticonvulsant medication * pre-existing renal disease * pre-existing cardiovascular disease * regular use of analgesic medication * having other procedures in addition to tonsillectomy (however, patients undergoing adenoidectomy with their tonsillectomy will be included in the study)
the effect of a probiotic strain on ibuprofen-induced gi damage

Conditions: Reduction of Small Intestinal Ulceration Risk

Summary: to investigate if a daily dose of minimum 15 billion cfu of bif195 reduces the risk of small-intestinal tissue damage in an ibuprofen challenge model as assessed by video capsule endoscopy in a healthy us population.

this trial is a single-site, randomized, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy volunteers aged 18 - 40 years. the trial will investigate the effect of daily intake of the probiotic strain bif195 or placebo when co-administered to daily intake of 800mg of ibuprofen. the trial includes a run-in period of two weeks duration followed by a six weeks intervention period where bif195/placebo and ibuprofen is co-administered. subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. besides the screening visit, the trial will consist of 5 visits. after having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. after baseline assessments at visit 2, subjects will start daily intake of 800mg of ibuprofen and also be randomly assigned to 6-weeks daily intake of bif195 or placebo product in a ratio of 1:1.

Eligibility criteria:
inclusion criteria: * written informed consent * healthy and without any gastrointestinal pain or other significant symptoms * age 18 - 40 years * willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial exclusion criteria: -
safety and efficacy of l-name and midodrine to increase map

Conditions: Orthostatic Hypotension; Spinal Cord Injury

Summary: after a spinal cord injury the brain is no longer completely in control of the body below the level of injury. this affects many organs and systems in the body, we are interested in understanding how a spinal cord injury affects blood pressure and blood flow to the brain. we are going to study blood pressure while the person is seated in a wheelchair before and after we give the subject medications which should increase blood pressure in a laboratory setting and over the course of a normal day in persons with spinal cord injury.

blood pressure regulation is compromised in persons with tetraplegia due to de-centralization of sympathetic cardiovascular control, associated with hypotension during upright positioning (7, 10, 18, 33). an alpha receptor agonist (midodrine hydrochloride) has been reported to raise blood pressure in persons with tetraplegia (25, 26, 30). midodrine is the only drug that is presently available to treat orthostatic hypotension. in the clinical armamentarium, it is always beneficial to have agents from multiple drug classes to treat a condition. in the treatment of hypertension, several classes of drugs may be prescribed to lower blood pressure, alone or in combination. the clinician and patient would benefit if another class of drug, with a totally separate mechanism of action, were available to treat orthostatic hypotension. a nitric oxide synthase inhibitor (nosi), nitro-l-arginine methyl ester (l-name), has been shown by our group to "normalize" blood pressure in persons with tetraplegia (32). the safety and efficacy of these two hypertensive agents has not been investigated or compared in persons with chronic tetraplegia. although the mechanism of action of each of these agents is appreciated, the relative cardiovascular effect in persons with sci compared with controls is not known. the study will determine the efficacy and safety of these two medications at restoring mean arterial pressure (map) during daily activities in persons with chronic tetraplegia. furthermore, the implication of restoring map to normal levels (80 10 mmhg) in individuals with tetraplegia on cardiovascular, autonomic, hormonal and cognitive function.

Eligibility criteria:
inclusion criteria: spinal cord injured subjects: * chronic spinal cord injury (1 year post injury) with a seated map of 65mmhg (almost all individuals with tetraplegia demonstrate this) * male or female with an age of 18 - 65 years control subjects: * male or female with an age of 18 - 65 years exclusion criteria: spinal cord injured subjects: * acute illness * cardiovascular disease * renal disease * medications that affect the cardiovascular system control subjects: * acute illness * cardiovascular disease * renal disease * medications that affect the cardiovascular system

Keywords: spinal cord injury orthostatic hypotension blood pressure midodrine hydrochloride l-name
life study: lifestyle intervention in fibroid elimination

Conditions: Uterine Fibroid

Summary: the study will evaluate a lifestyle, nutrition, and exercise program to assess whether this program is acceptable and feasible for patients..researchers will examine if the life program can modify fibroid recurrence.

this prospective cohort pilot study will enroll asymptomatic, post-surgical patients who underwent a laparoscopic, open, robotic myomectomy, or other procedure ie sonata, accessa for fibroid removal. patients will be offered enrollment into a lifestyle, nutrition, supplement, and exercise program to assess whether this program is acceptable and feasible for patients. surveys will be collected at 3-6 month intervals.

Eligibility criteria:
inclusion criteria: * participants ages 18-50, who are seeking care at the center for fibroid care at nyu * participants who have had a procedure or surgery performed to removed fibroids within the last 3 months and are now considered "fibroid free." * be english speaking and be able to read/write in english * visit with pcp within the last 3 months with labs exclusion criteria: * currently pregnant * use of any medication, hormonal or gnrh agonists, that would affect fibroid growth * postmenopausal women * non-english speaking * fibroid procedure or surgery outside of the 3-month window * women who are physically incapable of following a physical activity regimen * women with multiple dietary restrictions that would impact their ability to follow recommended dietary plan. (ie. gi disorders)
plerixafor harvesting and no chemotherapy for transplantation of autologous stem cells in cancer (phantastic)

Conditions: Multiple Myeloma; Plasma Cell Dyscrasia; Lymphoma; Lymphoproliferative Disorders

Summary: to assess the efficacy and toxicity of plerixafor (amd 3100) together with granulocyte-colony stimulating factor (g-csf) for stem cell mobilisation, in patients with myeloma or lymphoma requiring high dose chemotherapy with stem cell rescue.


Eligibility criteria:
inclusion criteria: * all of the following must be satisfied: aged 18 or over able to give informed written consent. diagnosis of either multiple myeloma or related plasma cell dyscrasia, or any form of lymphoma or associated lymphoproliferative disease autologous stem cell transplantation is planned as the next course of treatment. the patient has not previously undergone a mobilisation attempt for the current transplant. patients who have received previous autologous transplants at least 2 years previously are eligible, as long as stem cell mobilisation has not been attempted for the current transplant. no serious concomitant illness (e.g. heart disease) that might preclude completion of the study. creatinine clearance of at least 30 mls/min. note that a dose reduction of plerixafor is required where the creatinine clearance is between 30-50 mls/min; see section 3.3/5.1/5.3. negative pregnancy test in women of childbearing age. exclusion criteria: * unable to give informed written consent pregnancy or lactating creatinine clearance of less than 30 mls/min. patients with clearances lower than this may still be able to receive plerixafor at reduced dosage following discussion with the trial co-ordinators, but are not eligible for entry into this trial. any previous attempt at mobilisation for the current transplant. patients with any form of leukaemia, including plasma cell leukaemia, are not eligible.
psma pet scan and mpmri for prostate cancer detection

Conditions: Prostate Cancer Diagnosis

Summary: prospective, randomized, phase 2 clinical trial to determine if psma pet imaging plus mpmri improves detection of clinically significant prostate cancer as compared to mpmri alone.

this a prospective, randomized, phase 2 clinical trial. we will enroll patients who underwent mpmri of the prostate as part of their standard clinical care, have pi-rads 4, or 5 lesion(s) on mpmri, and are scheduled to undergo fusion guided prostate biopsy. subjects that sign the consent form will be randomized to undergo dcfpyl pet/ct imaging or no psma pet imaging prior to the prostate biopsy. in the psma scan cohort, decision for biopsy targets will be made based on the combination of the findings of mpmri and psma scans. in the no psma scan (control) group, the biopsy will be performed based on mpmri findings. each patient will undergo 12 core systematic biopsy as the standard of care. two additional biopsies for each mpmri and psma pet and overlap lesion will also performed.

Eligibility criteria:
inclusion criteria: * patients with pi-rads 4-5 lesion(s) on mpmri and have elected to undergo a prostate biopsy * prostate mpmri completed within 9 months prior to enrollment * patient capable of providing written informed consent * patient willing to be randomized to prostate mpmri only vs prostate mpmri + dcfpyl pet/ct exclusion criteria: * less than 18 years-old at the time of radiotracer administration * medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study procedures or compliance. * creatinine clearance exceeding institutional requirements for prostate mpmri

Keywords: psma petct prostate mpmri prostate needle biopsy dcfpyl pet/ct